TINA-QUANT FERRITIN ASSAY— 510(k) K964282

Name: FDA 510(k) clearance K964282
Creator: U.S. Food and Drug Administration
Published: 1997-07-30

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K964282 for TINA-QUANT FERRITIN ASSAY, Substantially Equivalent on 1997-07-30. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JMG
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1996-10-28
Decision date: 1997-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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